Aseptic connector and closure



.My 7, 1970 o. w. ANDERSON 3,519,153

ASEPTIC CONNECTOR AND CLOSURE Filed Sept. 27. 1968 2 Sheets-Sheet 1 //VVE/V TOR. DOUGLA$ w. ANDERSON Juiy 7, 1970 o. w. ANDERSON 3,519,153

ASEPTIC CONNECTOR AND CLOSURE Filed Sept. 27. 1968 2 Sheets-$heet 2 INVENTO/P DOUGLAS W. ANDERSON MM, fiaao rwa United States Patent O1 fice 3,519,158 Patented July 7, 1970 3,519,158 ASEPTIC CONNECTOR AND CLOSURE Douglas W. Anderson, Palatine, lll., assignor to Dave Chapman, Goldsmith & Yamasaki, Inc., Chicago, 11].,

a corporation of Delaware Filed Sept. 27, 1968, Ser. No. 763,097 Int. Cl. B65d 51/00 US. Cl. 21537 14 Claims ABSTRACT OF THE DISCLOSURE An aseptic connector and protective closure for use with a package containing intravenous fluids includes a plastic connector member having an aperture extending therethrough and an imperforate cap disposed over one end of the connector member. The cap includes an internal depending portion which extends into the aperture in the connector member to provide an aseptic seal, and an annular bead which is disposed in an annular groove in the connector member to lock the cap on the connector member. The connector member is injection molded in the cap to provide an aseptic seal between the connector member and the cap, which seal is maintained until the package is ready for use.

BACKGROUND OF THE INVENTION The present invention generally relates to a new and improved aseptic connector and protective closure for use with blood and other intravenous fluids, and the invention more particularly relates to an aseptic connector and closure for use with a package such as a flexible bag or bottle containing blood or other intravenous fluids.

In the past, in order to aseptically and hermetically seal the intravenous bottles, the separate parts of a multiple part connector and closure assembly were assembled on the bottle. For example, it was the usual practice to insert in the neck of the bottle an apertured rubber stopper and to cover the stopper with a rubber sheet and a metal band which were secured to the neck of the bottle. When the fluids were to be dispensed from the bottle, the metal band and the rubber sheet had to be removed. In tearing off the metal band and the rubber sheet, the rubber stopper could easily become contaminated by the person opening the bottle. Moreover, it was somewhat diflicult and time consuming to remove the metal band and rubber sheet.

The prior art type connector and closure assembly for the flexible bag container commonly used for packaging blood comprises a tube and a rubber stopper and has likewise been easily contaminated during use and the use of this assembly is unnecessarily time consuming in operation. Consequently, it would be desirable to have an asceptic connector and closure which is manufactured in such a manner that the closure provides an aseptic seal for the connector, and the closure maintains that same condition until the bottle or bag is ready for use.

Therefore, it is a principal object of the present invention to provide a new and improved aseptic connector and protective closure for use with blood and other intravenous fluids.

Another object of the present invention is to provide an aseptic connector and closure wherein the closure is aseptically sealed to the connector at the same time of manufacture.

Still another object of the present invention is to provide an aseptic connector and closure which can be easily and quickly used.

A further object of the present invention is to provide a new and improved aseptic connector and closure for use with intravenous bottles.

Still another object of the present invention is to provide a new and improved aseptic connector and closure for use with intravenous flexible bags.

SUMMARY OF THE INVENTION Briefly, the above and further objects of the present invention are realized in accordance with the present invention by providing an aseptic connector and closure, which includes a connector member having an aperture extending therethrough and an imperforate, protective cap disposed over and hermetically sealed to one end of the connector member. The cap is generally cup-shaped and includes a portion depending into the aperture to aseptically seal the connector member. An annular bead surrounds the cap near its rim and is tightly fitted in a complementary-shaped annular groove in the connector member to lock the cap on the connector member. The connector member is molded directly into the cap to provide an aseptic seal between the cap and the con nector member. Moreover, the cap has an external flange adjacent the bead to enable the user to readily and quickly remove the cap from the connector.

BRIEF DESCRIPTION OF THE DRAWINGS Further objects and advantages and a clear understanding of the present invention may be had by reference to the following detailed description taken in connection with the drawings, wherein:

FIG. 1 is a perspective view of a flexible bag embodying the connector and closure of the present invention;

FIG. .2 is an enlarged sectional view of the lower lefthand corner portion of the flexible bag including a connector and closure of FIG. 1;

FIG. 3 is an enlarged view of a portion of the connector and closure of FIG. 2;

FIG. 4 is a perspective view of the connector of FIG. 1, without the closure and with a tube connected to the bag by means of the connector;

FIG. 5 is an enlarged cross-sectional view which is similar to the view shown in FIG. 2, and which shows the connector without its closure;

FIG. 6 is a front view of an intravenous fluids bottle embodying another form of the connector and closure of the present invention;

FIG. 7 is an enlarged cross-sectional view of the upper portion of the bottle of FIG. 6 including the connector and closure;

FIG. 8 is an enlarged top view of the connector and closure of FIG. 6;

FIG. 9 is an enlarged view of a portion of the connector and closure of FIG. 7; and

FIG. 10 is an enlarged cross-sectional view which is similar to the view shown in FIG. 7, and which shows the connector without its closure.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings and more particularly to FIG. 1 thereof, there is shown in accordance with the principles of the present invention a flexible bag 10 having a pair of aseptic connectors and closure assemblies 12 and 14 at the bottom edge of the bag 10. The flexible bag 10 is made from suitable plastic film so as to be usable for packaging and dispensing intravenous fluids such. as blood. The bag 10 comprises a pair of flexible plastic sheets, such as the sheets 16 and 17 (FIG. 2), which are heat sealed together at their marginal edges to form a container. A pair of slits 18 located along the top marginal edge provide a means for attaching the bag 10 to an upright stand (not shown) during the use thereof.

3 In using the bag as a blood bag, the connector and closure assembly 12 is used for filling the bag, and the connector and closure assembly 14 is used for the administration of the blood from the bag.

Considering now the connector and closure of the present invention in greater detail, with reference to the drawings and more particularly to FIGS. 1, 2 and 3 thereof, only the connector and closure 12 is described since the connector and closure assembly 14 is identical to the connector and closure assembly 12. The connector and closure assemblies comprise a tubular connector member sealably secured in an opening 22 in the lower marginal edge of the bag 10 by means of localized heat sealing or by other suitable techniques, and an imperforate cup-shaped cap 24 disposed over the outer end portions of the connector 20. The connector 20 includes an aperture 26 extending therethrough for communicating with the interior of the bag 10 and for receiving a complementaryshaped tubular connector 28 (FIG. 4) of an intravenous tube 30 (FIG. 4). As best illustrated in FIGS. 1 and 4, an outwardly'extending annular flange 32 is provided on the connector 20 intermediate its ends to provide a stop shoulder for the cap 24. In order to provide a greater sealing area between the bag 10 and the connector 20,

a pair of diametrically opposed, longitudinally extending Webs or ribs 33 extend from the flange 32 to the internal end of the connector 20. As best shown in FIG. 3, the connector 20 includes an annular groove 34 adjacent the flange 32, and a complementary-shaped bead 36 on the cap 24 tightly fits in the groove 34 to sealably lock the cap 24 on the connector 20. The bead 36 is sufliciently long in cross section to lock the cap 24 on the connector 20, and the bead 36 is sufliciently short in cross section to permit it to be readily removed from the groove 36 upon removal of the cap 24 from the connector 20 and thus to permit a male mold member to be readily removed from the cavity of the cap 24 during the molding operation after the cap 24 is molded.

The aperture 26 includes a main cylindrical portion 37 adjacent a tapered portion 38. The tapered portion 38 is disposed adjacent a constricted cylindrical portion 41 which tightly receives the tube connector 28. The constricted portion 41 is disposed adjacent an outwardly flared end portion 43 of the aperture 26 at the external end of the connector 20. The aperture 26 also has an outwardly flared portion 44 at the internal end of the connector 20.

For the purpose of sealing the aperture 26 prior to use, the cap 24 has a centrally-disposed depending portion 45 which extends over the tapered portion 43 and the constricted portion 41 of the aperture 26. As hereinafter described in greater detail, the connector 20 is molded directly into the cap 24 so that the cap 24 and its depending portion 45 are disposed in sealing engagement with the connector 20. As a result, due to the relatively high temperatures required for molding the connector 20 directly into the cap 24, an aseptic seal is provided between the connector 20 and the cap 24 along the portions of the connector in contact with its cap. Thus, the cap 24 maintains a substantial portion of the outer surface of the connector in an aseptic condition and no further sterilization of the outer surfaces of the connector 20 is required. For this reason, the connector and closure assembly 12 is inexpensive to use since it is inherently maintained in an aseptic condition from the time of manufacture.

In order to enable the cap 24 to be grasped for quickly and easily removing it from the connector 20, the cap 24 is provided with an outwardly-extending external flange 47 adjacent the head 36. The annular flange 47 extends beyond the periphery of the flange 32 of the connector 20 and the webs 33, to permit the flange 47 to be readily grasped for the purpose of removing the cap 24 from the connector member 20 without tending to contaminate it by the hand of the user. Once removed, the cap 24 cannot be replaced on the connector 20 mainly 4 due to its locking bead 36 so that there is no chance of contamination due to accidentally replacing the cap 24 on the connector member 20.

In order to economically manufacture the connector and closure assembly 12 and at the same time provide an aseptic seal between the connector and the cap, the assembly may be made by the following method.

In accordance with this method, the cap 24 is first formed of plastic in an injection molding operation wherein a female mold defines the outer surface of the cap 24 and a male mold member defines the inner surface of the cap 24. While the cap 24 is preferably composed of a linear polyethylene and injection molded, it may, however, be stamped from metal, such as aluminum, or it may be thermoformed of a thermoformable plastic or formed of some other suitable material. Assuming that the cap 24 has been formed in an injection molding operation, the male mold member is removed from the cavity within the cap 24 and a male mold member having a mold surface conforming to the inner surface of the connector member 20 is moved into place and the connector member 20 is then injection molded between this male mold member and the cap 24. The cap 24' thus functions as a portion of the mold during the injection molding of the connector member 20. In this manner, the connector member 20 conforms to the inner surface of the cap 24. Thus, in order to inexpensively manufacture the connector and closure 12 in this two-step operation and to provide the outwardly tapered portion 43 of the aperture 26, the depending portion of the cap 24- is the core during molding of the connector 20. As a result of this molding technique, the connector and closure assembly 12 can be molded in a two-step automatic operation with simple molds. Moreover, a hermetic and aseptic seal is provided at this time by the upper marginal end of the connector member 20 which tightly fits into the annular recess in the cap surrounding the depending portion 45. This sterile seal of the outer surface of the connector member 20 is automatically accomplished by virtue of the fact that the plastic is relatively hot, being of the order of 250-350 degrees B, when it is injection molded between the male mold member and the cap 24. Since a seal is provided at this time between the cap 24 and the connector member 20 and such a seal remains intact until the cap 24 is removed, no further sterilization of the outside of the closure is required. Of course, the inner surfaces will require sterilization and this may be accomplished in a manner well known in the art.

The connector member 20 should be formed of plastic so as to be injection moldable directly against the surface of the cap 24, and the plastic chosen for the connector member 20 should have a melting point substantially lower than the melting point of the material from which the cap 24 is formed so that the connector member 20 does not form a bond with the cap 24 whereby removal of one cap 24 would be otherwise prevented. Where the cap 24 is formed of metal, most plastics can be used to form the connector member 20. Where the cap 24 is polyethylene, the connector member 20 may be formed of vinyl or a vinyl compound such as ethylvinylacetate acid by E. I. du Pont de Nemours & 00., under the name, E.V.A.

Referring now to FIGS. 6 to 10, there is shown another form of the connector and disclosure assembly of the present invention. Referring in particular to FIG. 6, there is shown an intravenous container 50 including a glass bottle 52 and a connector and closure assembly 54 sealed to the top of the bottle 52. The bottle 52 may be composed of glass or similar material, such as plastic laminated material. The connector and closure assembly 54 provides a cover and seal for the bottle 52 to maintain the contents in a sterile condition. A handle 56 .iS provided for attaching the intravenous container 50 to a stand, it being understood that during use the intravenous container 50 is hung in an inverted position relative to the position shown in FIG. 6.

As shown in FIGS. 7, 8, 9 and 10, the connector and closure assembly 54 includes an injection molded, resilinet plastic member 58 which is disposed in and seals the mouth of the bottle 52, and a flexible, imperforate cap 60 which is sealably secured to and over the member 58 when the connector and closure assembly 54 is manufactured. The member 58, which in the illustrated embodiment of the invention functions as a stopper and connector for the bottle 52, is injection molded directly into the previously formed cap 60 so as to have an external surface which conforms in part to the internal surface of the cap 60, in the same manner as described above in connection with the connector and closure assembly 12. Due to the elevated temperature of the molding operation, the cap 60 is an aseptic seal for the member 58.

As best shown in FIG. 9, in order to sealably lock the cap 60 on the member '58, the cap 60 includes an annular internal peripheral bead portion 62 which is disposed in a complementary-shaped annular peripheral groove 64 in the member 58. The bead 62 is sufficiently long to mechanically lock the cap 60 on the member '58, but the bead 62 is sufliciently short to permit the cap 60 to be readily removed from the member 58 to open the bottle 52. For the purpose of permitting the cap 60 to be grasped to quickly and easily remove it from the member 58, the cap 60 is provided with an outwardlyextending annular flange 65 adjacent the bead portion 62.

The connector member 58 is generally cup-shaped and has a centrally-disposed depending plug portion 66 which fits snugly in the mouth of the bottle 62 to hermetically seal it. The connector member 58 has a beveled, annular re-entrant flange portion 68 which is disposed at the inner periphery of the cup-shaped member 58, whereby the inner surface of the cup-shaped member 58 is complementary-shaped with respect to the outer surface of the rim portion 71 and the top edge portion of the mouth of the bottle 52 thereby to mechanically lock the member 58 to the rim portion 71 of the bottle 52. The member 58 is also tightly locked to the top of the bottle 52 by means of atmospheric pressure once the bottle 52 is sterilized during autoclaving which evacuates the container 50. The stopper portion 66 of the member 58 includes a pair of spaced-apart holes 73 and 75 ex tending through the stopper portion of the member '58. The hole 73 tightly receives a tubular connector of an intravenous tube and is similar to the aperture 26 of the connector 20 of the above-described connector and closure assembly 12. When the cap 60 is removed, a tubular connector of an intravenous tube can be inserted into the aperture 73 to connect the tube in fluid communication with the interior of the bottle 52. A dip tube 77 fits tightly within the aperture 73 and extends from a location near the external surface of the member 58 to a location near the opposite closed end of the bottle 52 to provide a vent passageway during the use of the container 50. The dip tube may be composed of either glass or plastic material.

As shown in FIG. 7, the imperforate cap 60 is preferably composed of a linear polyethylene but may be composed of a metal such as aluminum. The cap 60 includes a downwardly-depending portion 79 which sealably covers the aperture 73 and which is complementaryshaped relative to an outwardly flared portion 80 of the aperture 73 in the external end of the member 58 to sealably cover the aperture 73 in the same manner that r 82 of the cap 60 is disposed. The depending portion 82 is the core for molding the constricted portion 84 of the aperture 75 during the manufacture of the connector and closure assembly 54 so that the depending portion '82 seala'bly covers the tube 77. Due to the elevated temperature of the plastic material during the molding operation, the depending portions 79 and 82 are aseptic seals for the apertures 73 and 75, respectively.

-As shown in FIGS. 7 and 8, for the purpose of evacuating the sealed bottle 52 during its sterilization, the depending portion 79 serves as a pressure relief valve member during the sterilization process, which may be accomplished 'by known autoclaving techniques. In this regard, when the package 50 is heated by steam under pressure, the air and fluid in the bottle 52 expand to cause the depending member 79 to move outwardly relative to the member 58 to release the hot gases from within the bottle 52. In order to permit the depending portion 79 within the flared portion of the aperture 73 to move relative to the member '58, the member 58 has four equally-spaced raised portions 58', the top surface of which conforms to the flat top surface of the cap 60. The raised portions 58' extend through four complementary-shaped openings '86 (FIG. 8). The openings 86 provide an area of weakness around the depending portion 79 to enable the expanding air and liquid to force to depending portion 79 outwardly and permit the interior to communicate with atmosphere via the openings 86. For the purpose of permitting the interior of the bottle to communicate with the atmosphere with only a relatively small movement of the depending portion 79, the flared portion 80 of the aperture 73 enables a passageway to be formed between the interior of the bottle and the atmosphere as soon as the bottom of the depending portion 79 enters the flared portion 80 of the aperture 73. Upon lowering the temperature of the container 50, the depending portion 79 of the cap 60 moves under the force of atmospheric pressure inwardly into sealing engagement with the member 58.

In view of the foregoing description, it should now be apparent that there is provided in accordance with the present invention a new and improved aseptic connector and closure assembly for a package containing blood or other intravenous fluids. The inventive connector and closure assembly includes a connector having an aperture extending therethrough and a closure which is aseptically sealed over the aperture upon manufacturing the assembly. The closure remains aseptically sealed over the aperture until the closure is removed from the connector. Moreover, a mechanical interlock in the form of an annular bead on the closure and a complementaryshaped groove of the connector is provided to lock the closure on the connector and to insure that the closure was not previously removed since, once the closure is removed, it is a difficult task to replace the closure on the connector.

While the present invention has been described with particular embodiments thereof, it will be understood that those skilled in the art may make many changes and modifications without departing from the true spirit and scope of this invention and, accordingly, all such changes and modifications which fall within the true spirit and scope of this invention are intended to be covered in the appended claims.

I claim:

1. An aseptic connector and closure assembly for use with intravenous fluids, said assembly being adapted to be used with an intravenous tube having a tube connector, comprising a connector member molded of plastic and adapted for receiving said tube connector of said intravenous tube, said connector member having an aperture extending therethrough for tightly receiving said tube connector, and

an imperforate cap disposed over one end of said con-- nector member,

said cap having a portion depending into said aperture,

said connector member being molded directly into said cap to aseptically seal said connector member with said cap.

2. An aseptic connector and closure assembly according to claim 1 wherein said connector member includes means defining an annular groove, and said cap includes an annular bead disposed in said groove and an outwardly-extending external flange on said cap adjacent said bead.

3. An aseptic connector and closure assembly according to claim 2 wherein an annular flange is provided on said connector intermediate the ends thereof, said annular groove in said connector being disposed adjacent said flange, and said external flange extending outwardly beyond the periphery of said flange on said connector member.

4. The invention set forth in claim 3 wherein said connector is provided with a pair of diametrically opposed, longitudinal flanges disposed between said annular flange thereon and the other end thereof.

5. The invention set forth in claim 1 wherein said aperture is outwardly tapered at the end thereof receiving said depending portion of said cap.

6. The invention set forth in claim 1 wherein said connector member is generally cup-shaped and has a centrally-disposed depending portion through which said aperture extends, said annular groove in said connector being disposed at the outer rim of the connector, and said outwardly-extending flange on said cap extending outwardly beyond the periphery of said flange on said connector member.

7. The invention set forth in claim 6 further including a second aperture extending through said connector member, and a second depending portion depending into said second aperture.

8. The invention set forth in claim 1 wherein said cap is composed of a flexible material and said aperture includes an outwardly flared portion at the external end of said connector member, and further includes means defining a plurality of apertures in said cap disposed near said depending portion, and said connector member includes a plurality of raised portions disposed in the last-mentioned apertures, whereby said depending portion 'is' movably mounted within the first-mentioned aperture.

9. The invention as set forth in claim 1 wherein said connector member and said cap are formed of plastics having different melting points.

10. A container and connector for use in packaging and feeding intravenous fluids, comprising,

a flexible, plastic bag and the connector and closure as set forth in claim 1 positioned in an opening in the wall of said bag and sealably secured thereto.

11. The invention set forth in claim 10 wherein said bag 'is formed of two sheets of plastic film sealed together along the marginal edges thereof, and

said connector extends into said bag at the marginal edge thereof between said sheets.

12. The invention set forth in claim 11 wherein said connector has a pair of diametrically opposed longitudinal flanges respectively extending between said sheets and heat sealed thereto.

13. A container and connector for use in packaging and feeding intravenous fluids, comprising,

a rigid bottle and the connector and closure as set forth in claim 1 positioned in the mouth of the bottle and sealably secured thereto.

14. The invention set forth in claim 13 wherein said connector extends into said mouth of said bottle and includes an internal annular flange to engage the rim of said bottle at said mouth thereof.

References Cited UNITED STATES PATENTS 1/1961 Baumann 2l537 7/1968 Bathish et al. 2l5-42 GEORGE T. HALL, Primary Examiner 

